21 CFR 820.181 Device Master Record

Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:

(a) 

Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;

(b) 

Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;

(c) 

Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;

(d) 

Packaging and labeling specifications, including methods and processes used; and

(e) 

Installation, maintenance, and servicing procedures and methods.